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Endpoints: BIO Comments on FDA Multiple Endpoints in Clinical Trials

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance “Multiple Endpoints in Clinical Trials” (Draft Guidance).

First-in-Human: BIO Submits Comments to EMA on Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

The Biotechnology Innovation Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the “Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.” 

BIO Statement on President Trump’s Comments Supporting Biopharmaceutical Competition and Innovation

Washington, DC (January 31, 2017) – BIO issued the following statement regarding President Trump’s comments today supporting biopharmaceutical innovation:

BIO Applauds Senate Passage of the 21st Century Cures Act

Washington, DC (December 7, 2016) – Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement today regarding passage of the 21st Century Cures Act by the U.S. Senate:

BIO Applauds House Passage of the 21st Century Cures Act

Washington, DC (November 30, 2016) – Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement today regarding passage of the 21st Century Cures Act by the U.S. House of Representatives:

BIO Statement on FDA Product Communications Hearing

BIO President and CEO Jim Greenwood released the following statement today regarding the FDA’s hearing on product communications: “In the era of data-driven medicine, where all parties seek more, not less, information about the safety, effectiveness, and value of treatments, fostering informed communications among all stakeholders is critical.  We are in the midst of a transition to value-based healthcare – a transition that has the potential to improve the efficiency of the overall healthcare system. Earlier this year, BIO and its members endorsed a systemic set of principles and commitments in support of moving us toward a value-based system – the first major healthcare industry association to do so.  

Codevelopment: BIO Comments on FDA Draft Guidance Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product

Re: Docket No. FDA-2016-D-1703

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Electronic Health Record Data: BIO Comments on FDA Draft Guidance Use of Electronic Health Record Data in Clinical Investigations

Electronic health record (EHR) data and “real world evidence” generated from the post-marketing clinical use of medicines can provide valuable information regarding the use, benefits, or risks of therapies. BIO applauds FDA for taking steps to provide greater clarity around the use of EHR data in clinical assessments of safety and effectiveness in regulatory submissions.

New Report Shares Best Practices for the Development of Disease-Specific Patient Preference Studies

 San Francisco, CA (June 8, 2016) – Today, the Biotechnology Innovation Organization (BIO) and Parent Project Muscular Dystrophy (PPMD) released a new report, “Key Considerations for Developing and Integrating Patient Perspectives in Drug Development: Examination of the Duchenne Case Study.” 

New Report Shares Best Practices for the Development of Disease-Specific Patient Preference Studies

Today, the Biotechnology Innovation Organization (BIO) and Parent Project Muscular Dystrophy (PPMD) released a new report, “Key Considerations for Developing and Integrating Patient Perspectives in Drug Development: Examination of the Duchenne Case Study.”